pPSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. /p h3Job Description /h3 pJoin our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. /p pHybrid working arrangementin Milan area /p h3Your role: /h3 ul liSupport country-level regulatory activities for Italy under the EU Clinical Trials Regulation (CTR)



/li liPrepare and coordinate CTR Part II submission packages for Italy /li liCommunicate with regulatory authorities,project teams and vendors on regulatory-related matters /li liReview translations of essential documents subject to clinical trial submission /li liTrack the regulatory project documentation flow /li liReview documents to greenlight IP release to sites /li /ul h3Qualifications /h3 ul liScientific University degree or an equivalent combination of education, training and experience /li liPrevious experience with CTR Part II submissions for Italy is mandatory /li liFull working proficiency in English and Italian /li liProficiency in MS Office applications /li liDetail-oriented /li liAbility to learn, plan and work in a dynamic team environment /li liCommunication, collaboration, and problem-solving skills /li /ul h3Additional Information /h3 ul liBase salary range: €36,000 – €46,000 gross annual salary. /li liActual compensation: The salary offered within the stated range will depend on objective, job-related criteria, including demonstrated competencies, qualifications, and skills relevant to the position. /li liAdditional compensation: premio, incentive plans, and other benefits may apply. /li /ul #J-18808-Ljbffr

📌 Regulatory Officer (Milano)
🏢 SmartRecruiters
📍 Milano